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MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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| Model Number ENVPRO-16 |
| Device Problems
Difficult or Delayed Positioning (1157); Difficult to Advance (2920); Material Twisted/Bent (2981); Patient Device Interaction Problem (4001)
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| Patient Problem
Vascular Dissection (3160)
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| Event Date 02/22/2023 |
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Event Type
Death
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Event Description
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Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve, into a patient with a slightly " unfolded" aorta, a pre-implant balloon aortic valvuloplasty (bav) was performed using a 23 mm non-medtronic (valver) balloon.A lunderquist wire was used for the implant.The valve was loaded successfully.While crossing the native valve with the delivery catheter system (dcs), the physician noted resistance, and that the nosecone of the dcs appeared bent at the non-coronary cusp (ncc).The physician was advised to withdrawn and loosen the nosecone slightly.The dcs was crossed further in another attempt, however the valve was positioned too high on the initial deployment, observed at 80% deployed, therefore the valve was recaptured in the ascending aorta.At this point, it was reported that the position of the pigtail catheter was lost in the ncc, therefore a j wire was inserted into the pigtail catheter to reposition it.During an aortogram to confirm the position of the pigtail catheter, a dissection in the ascending aorta and ncc was observed.The dcs was withdrawn from the patient.The patient was transferred for a surgical repair anda surgical aortic valve replacement.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Updated data: b5 - event description d9 - device available for evaluation and return date h1 - type of reportable event updated to death h3 - device evaluated and device returned to manufacturer h6 - method, results and conclusion codes h10 - product analysis: the device was returned, and device evaluation anticipated but not yet begun.Conclusion: the investigation is in progress.Additional codes - imf code medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received that the patient's slightly "unfolded" aorta meant widened and decreased curvature of the aortic arch.During the valve implant, the delivery catheter system (dcs) was manipulated in the ascending aorta.An aortic aneurysm repair was performed for the dissection.Per the physician, the cause of the dissection was unknown and it was unknown if the delivery catheter system (dcs) contributed to the dissection.The patient went into the intensive care unit (icu) and died a few days later.The cause of death was not reported.
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Manufacturer Narrative
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Corrected data: regulatory report #2025587-2023-00690 follow up 001 - the follow fields were erroneously not mentioned on the follow up report.A1 - patient identifier was updated a2 - age at event was updated medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product analysis: upon receipt at medtronic¿s quality laboratory, the delivery catheter system (dcs) was received without a valve loaded within the capsule.The handle was intact.The device was received with the nosecone over-capturing the capsule.The deployment knob retracted and advanced the capsule.The trigger moved to fully advance and retracted positions with resistance noted and locked in place when released.The tip-retrieval mechanism was intact with resistance noted when tested.The device was returned with the end cap/screw gear snap fit connected.There was damage observed on the threading of the screw gear.Delamination was observed over the nitinol reinforcing frame on the distal section and the proximal end of the capsule.The inner member shaft and spindle hub were intact with no evidence of damage.There was a kink to the proximal end of the stability shaft.There was a kink to the middle shaft and outer shaft at the same overlapping point.Conclusion: the investigation is in progress.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Corrected: a1, a2.Select patient information cannot be included in regulatory report due to regional privacy regulations.A1 and a2 were inadvertently submitted and should be considered redacted.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Corrected h6 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Conclusion: intra procedural angiogram images were provided for review of the event.The patient¿s executive summary was provided for anatomical review.From the patient¿s executive summary, there was no evidence of aortic root dissection.The aortic root aortogram did not show evidence of aortic dissection.A pre-implant balloon aortic valvuloplasty (bav) was performed.Evidence of an aortic root dissection is visible in subsequent images.The evidence suggests the dissection occurred after the pre-implant dilatation of the aortic valve.The subject delivery catheter system (dcs) was returned to medtronic for analysis.The device was received with the capsule over-captured.The device instructions for use (ifu) cautions the user to ¿stop advancing the capsule once the gap to the catheter tip is closed.Advancing the capsule farther could damage the capsule¿.There was damage observed on the threading of the screw gear.This damage is consistent with the increased forces in the system.High forces in the handle may cause the threading of the screw gear to become worn and damaged.Delamination was observed on the capsule, which typically occurs when the capsule is subjected to a bending force potentially after tracking through tortuous anatomy.Multiple kinks on the dcs were observed at the strain relief, the middle shaft, and the outer shaft.No bend was noted on the nose cone of the device.The description of the event does not indicate that this damage occurred during the reported event, however the device was returned coiled in a large box, which may have caused the kinks to the device.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Difficulties advancing the delivery catheter system (dcs) through the access vessel is known to be related to factors such as patient anatomy and physician technique, including guidewire and introducer sheath selection.In this case, it was noted that the patient's slightly "unfolded" aorta meant widened and decreased curvature of the aortic arch.This indicates that the probable cause of the advancement difficulties was patient anatomy, but this cannot be confirmed with the limited information available.The nosecone may have bent due to the difficulties advancing the dcs, but the images provided for review could not confirm the root cause.Recapturing is a feature of the device that allows for additional attempts at accurately positioning the valve.Various factors can affect valve positioning including patient anatomy or physician technique.There is no information to suggest a device quality deficiency that may have caused or contributed to this event, but the cause of the positioning difficulty could not be conclusively determined with the available evidence.Positioning difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.Vascular related complications, such as patient death and dissection, are a known potential adverse patient effect per the device ifu, and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).Per the physician, the cause of the dissection was unknown, and it was unknown if the dcs contributed to the dissection.Based on the information provided, it is possible that the delivery catheter system was related to the dissection.It was noted that resistance was felt as the dcs crossed the annulus and that the nosecone of the dcs appeared bent at the non-coronary cusp.It is also possible that the wire that was advanced into the pigtail could have been related to the dissection as it was reported that the dissection was noted when confirming placement of the wire.The dissection was repaired surgically, and a surgical aortic valve was implanted.It was reported that the patient died a few days after the implant, however, the physician did not confirm the cause of death.All adverse events and severities noted in this event are documented in the risk management files and within the ifu.No further safety assessment required, and no further action is needed as this complaint did not identify any unexpected serious adverse events.There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.Updated: h6 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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